# K211420: Stasis Gel

- Pathway: 510(k) (Traditional)
- Applicant: Belport Company, Inc., Gingi-Pak
- Decided: Mar 14, 2022 after 311 days
- Product code: MVL (Cord, Retraction)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K093711 (2010). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190220: Vista FS, Vista FS Liquid, Inter-Med/Vista Dental Products (2019) Summary page 4.

## Indications for use
STASIS Gel is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord. STASIS Gel facilitates the insertion of the cord into the sulcus.

Source page: https://510kreport.com/device/K211420
Methodology: https://510kreport.com/methodology